Acknowledgment: The authors thank the research assistants and case managers for their support with the design and implementation of this study: Carla Berg, PhD; Genevieve Casey; Olivia Chang; Andrea Elyachar; Tresza Hutcheson; Shawn Jeffries, PhD; and Terri Tapp. They also thank Harry Lando, PhD, University of Minnesota School of Public Health, for his scientific contributions to the study concept and design.

Grant Support: From the National Cancer Institute (grant R01-101963). Study medication was provided by GlaxoSmithKline.

Pharmacotherapy utilization was similar across treatment groups, with 473 of 741 (63.8%), 302 of 739 (40.9%), 175 of 732 (23.9%), and 179 of 726 (24.7%) participants requesting pharmacotherapy during the first, second, third, and fourth 6-month treatment cycles, respectively. Of participants who saw a physician during any given treatment cycle, 37.5% to 59.5% reported that they had discussed smoking cessation with their physician; this did not differ across the treatment groups. Abstinence rates increased throughout the study, and overall (0 to 24 months) analyses demonstrated higher abstinence among the high-intensity disease management group than the moderate-intensity disease management group (odds ratio [OR], 1.43 [95% CI, 1.00 to 2.03]) and among the combined disease management groups than the pharmacotherapy-alone group (OR, 1.47 [CI, 1.08 to 2.00]). Self-reported abstinence at 24 months was 68 of 244 (27.9%) and 56 of 238 (23.5%) participants in the high- and moderate-intensity disease management groups, respectively (OR, 1.33 [CI, 0.88 to 2.02]), and 56 of 244 (23.0%) participants in the pharmacotherapy-alone group (OR, 1.12 [CI, 0.78 to 1.61] for combined disease management vs. pharmacotherapy alone).

Limitation:

The effect of pharmacotherapy management cannot be separated from the provision of free pharmacotherapy, and cessation was validated in only 58% of self-reported quitters.

Conclusion:

Smokers are willing to make repeated pharmacotherapy-assisted quit attempts, leading to progressively greater smoking abstinence. Although point-prevalence abstinence did not differ at 24 months, analyses that incorporated assessments across the full 24 months of treatment suggest that higher-intensity disease management is associated with increased abstinence.